UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029184 |
|---|---|
| Receipt number | R000033366 |
| Scientific Title | Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression |
| Date of disclosure of the study information | 2017/09/19 |
| Last modified on | 2022/09/15 16:13:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Acronym
Stress check study
Scientific Title
Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Scientific Title:Acronym
Stress check study
Region
| Japan |
Condition
Condition
subthreshold depression
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of the internet-based guided self-help cognitive behavioral therapy with subthreshold depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The Center for Epidemiological Studies Depression scale (CES-D)
Key secondary outcomes
1. Beck Depression Inventory-II (BDI-II)
2. General Health Questionnaire-12 (GHQ12)
3. QOL (EQ-5D-5L)
4. Sheehan Disability Scale (SDISS)
5. Presenteeism (Stanford Presenteeism Scale (SPS)
6. Cognitive Control Scale
7. Quick Inventory of Depressive Symptomatology (QIDS-J)
8. Session Rating Scale (SRS)
9. Onset of depressive disorders at the 36 weeks follow-up
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Internet-based guided self-help cognitive behavioral therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 66 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Workers with high stress-related symptoms and conditions assessed by the Stress Check Test
2. The Center for Epidemiological Studies-Depression (CES-D) > = 16 at the baseline
3. Age 20 years or older, and 65 years or younger at the baseline
4. Subjects who give full consent in the participation of the study
Key exclusion criteria
1. Subjects with current DSM-IV major depressive disorder or during treatment for depression at the baseline
2. Subjects with manic episode or psychotic disorders or during treatment for bipolar disorder or psychotic disorders at the baseline
3. During treatment with antidepressant, mood stabilizer or antipsychotics at the baseline
4. Serious suicidal ideation at the baseline
5. Structured psychotherapy during the intervention
6. Other relevant reason decided by the investigators
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Reiji |
| Middle name | |
| Last name | Yoshimura |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Psychiatry
Zip code
807-0804
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL
093-691-7253
yoshi621@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Utsunomiya |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Psychiatry
Zip code
807-0804
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
TEL
093-691-7253
Homepage URL
k-utsu@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan
Tel
093-691-7205
daigakukanri@mbox.pub.uoeh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 19 | Day |
Last modified on
| 2022 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033366
